It’s not a law, it’s not a regulation, it’s an international standard for quality management systems. ISO 13485 is specific to the medical device industry, but it can be used by any company in the industry. This includes industrial design firms, translation services, contract manufacturers, contract sterilizers, contract research organizations, and companies that provide services such as installation, repair, or user training. Even a consulting firm like Medical Device Academy can use ISO 13485 to ensure the quality of our consulting services.

The purpose of establishing a quality system is to provide a set of rules for your company to follow to ensure that everyone knows what to do, and how to do it, and when something goes wrong you have the documentation available to figure out why. An ISO 13485 quality system also ensures that you are following the medical device regulatory requirements in each country where you sell a device.

If your company implements a quality system that is compliant with ISO 13485, you will need to create the following documentation:
➤ A quality policy
➤ Quality objectives
➤ A quality manual
➤ Procedures
➤ Detailed work instructions
➤ Records

Most medical device manufacturers will request a copy of your ISO 13485 certificate as a method of qualifying new suppliers. Therefore, you may want ISO 13485 certification for marketing purposes to get your company more business. However, as a contract manufacturer, it is not a regulatory requirement to be ISO 13485 certified.

The standard does not tell you exactly what your procedures should say. There are no templates provided in the standard. In fact, you can’t even find examples in the standard. Therefore, whatever someone tells you, there are multiple ways to meet any requirement in ISO 13485. Unfortunately, that also means that there are a lot of bad practices that you shouldn’t copy because they don’t meet the requirements.

If you want to purchase a copy of ISO 13485:2016, we recommend the following source as the least expensive we are aware of:
➤ [ Ссылка ]

ISO 13485 is divided into numbers Clauses beginning with Clause 0, the introduction, and ending with Clause 8, measurement, analysis, and improvement. Unlike ISO 9001, ISO 13485 differentiates between clauses that are not applicable and clauses that are excluded. In ISO 13485, you can only exclude design, which is Clause 7.3. For non-applicability, you can only claim clauses or subclauses within Clauses 6, 7, and 8 as not applicable. The rationale for non-applicability must be justified as being non-applicable to your device or the activities you perform. For example, if your company makes devices that do not need to be sterile, then sub-clause 7.5.5 (particular requirements for sterile medical devices) does not apply.

As stated in Clause 0.3, ISO 13485 is based on the process approach to quality management. That means, for your company to operate effectively, you shall identify and manage a number of linked processes. Each process can be defined using seven elements:
1. Description of the process
2. Process inputs - records and raw materials
3. Process outputs - records and finished devices
4. Equipment and work environment
5. Human resources
6. Procedures and forms
7. Process metrics

Here’s an outline of the remaining clauses in the ISO 13485 standard:
1. Scope
2. Normative references
3. Definitions
4. Quality management system
5. Management responsibility
6. Resource management
7. Product realization
8. Measurement, analysis, and improvement

If your company wants to establish an ISO 13485 quality system, you can purchase procedures, write procedures, or a combination of the two. However, establishing the quality system is only the beginning. It requires a lot of documentation (paper or electronic) and you need to continuously monitor the processes and make corrections or improvements to sustain the quality system. Therefore, you will need to track metrics for every process, you will need to perform at least one full quality system internal audit each year, and you will need to conduct at least one management review each year. Every time a change is made to a process, you will need to review and approve the changes in writing, you may need to retrain people on the new process, and the changes never stop. Therefore, it is important to have management support for the quality system and for people to have the mindset that the quality system requires diligence throughout the entire year to maintain quality system effectiveness.

If you need help implementing your ISO 13485 quality system, please watch our step-by-step video on obtaining ISO 13485 certification:
➤ [ Ссылка ]

If you would like to schedule a call with Rob Packard, please use his calendly link:
➤ [ Ссылка ]

свернуть